Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Pancreatic Cancer
Information source: ImClone Systems
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: Cetuximab + Bevacizumab (Drug); Cetuximab + Bevacizumab + Gemcitabine (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: ImClone Systems Official(s) and/or principal investigator(s):
Andrew Ko, MD, Principal Investigator, Affiliation: University of California, San Francisco
Summary
Eligible patients with pancreatic cancer will be treated with dual agent monoclonal antibody
consisting of cetuximab and bevacizumab alone or in combination with gemcitabine
Clinical Details
Official title: A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Progression-free survival of patients with stage IV adenocarcinoma of the pancreas treated with either dual monoclonal antibody therapy consisting of
cetuximab and bevacizumab or cetuximab and bevacizumab in combination with gemcitabine chemotherapy.
Secondary outcome: Overall survival (OS)Response rate in the subset of patients with measurable disease by RECIST CA19-9 response rate in the subset of patients with elevated baseline values Time to progression Safety and tolerability Quality of Life and pain control assessments Evaluation of pharmacodynamic parameters, including analysis of tumor tissue, if available, for EGFR expression and for exploratory markers of tumor progression or response to therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The patient has provided signed written informed consent.
- The patient is ≥18 years of age.
- The patient has histologically or cytologically-confirmed pancreatic adenocarcinoma
not amenable to curative treatment with surgery or has documented or suspected
extrapancreatic metastases.
- The patient has either (a) measurable disease as defined by Response Evaluation
Criteria in Solid Tumors (RECIST) (see Section 11. 3) or (b) non-measurable disease
with an elevated baseline CA19-9 level (≥2 x the upper limit of normal [ULN]).
- The patient's ECOG performance status is ≤2.
- The patient has adequate hematologic function as defined by an absolute neutrophil
count (ANC) ≥1500/mm3 and a platelet count ≥100,000/mm3 obtained within 2 weeks prior
to the first dose of study medication.
- The patient has adequate hepatic function as defined by a total bilirubin ≤2. 0 mg/dL
and transaminases ≤5. 0 x ULN obtained within 2 weeks prior to the first dose of study
medication.
- The patient has adequate renal function as defined by serum creatinine ≤2. 0 x ULN and
urine dipstick for proteinuria ≤1+ obtained within 2 weeks prior to the first dose of
study medication. If urine dipstick is ≥2+, then a 24-hour urine for protein must
demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
Urinalysis is also acceptable.
- If the patient is on full-dose anticoagulation therapy (eg, warfarin or low molecular
weight [LMW] heparin), the following criteria must be met:
- The patient has an in-range INR (usually between 2 and 3) on a stable dose of
oral anticoagulant or be on a stable dose of LMW heparin
- The patient has no active bleeding or pathological condition that carries a high
risk of bleeding (e. g., tumor involving major vessels or known varices)
- If the patient is not on full-dose anticoagulation therapy, the following criteria
must be met:
- The patient has adequate coagulation function as defined by INR ≤1. 5
- The patient has a PTT ≤ULN obtained within 2 weeks prior to the first dose of
study medication
- If a woman, the patient agrees to use an accepted and effective method of
contraception (hormonal or barrier methods, abstinence) prior to study entry and for
the duration of the study. If a male and sexually active, the patient agrees to use
effective contraception.
- The patient is accessible for treatment and follow-up. Patients enrolled in this trial
must be treated at the participating center.
Exclusion Criteria:
- Endocrine tumors or lymphoma of the pancreas
- Known brain metastases
- Prior therapy with an EGFR inhibitor or VEGF inhibitor
- Prior chemotherapy, hormonal therapy, or radiation therapy for advanced pancreatic
cancer, patients who received chemotherapy and/or radiation therapy in the adjuvant
setting will be eligible as long as the adjuvant therapy was completed >6 months
prior
- Concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of
the cervix
- Concurrent treatment with other anti-cancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations
- History of arterial thrombotic events within 9 months
- History of uncontrolled hypertension (>150/100 mmHg) not on a stable regimen of
anti-hypertensive therapy
- History of significant bleeding events or upper or lower gastrointestinal bleeding
within 9 months
- History of gastrointestinal perforation within 12 months
- Serious non-healing wound ulcer, bone fracture, or major surgical procedure with 28
days
- If a woman, is pregnant or lactating
- An employee of the investigator or study center as well as family members of the
employees
Locations and Contacts
Clopton Clinic, Jonesboro, Arizona 72401, United States
UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States
Hematology Oncology, PC, Stamford, Connecticut 06902, United States
Hematology & Oncology Consultants, Orlando, Florida 32804, United States
M. D. Anderson Cancer Center Orlando, Orlando, Florida 32806, United States
Advanced Medical Specialties, Miami, Florida 33176, United States
Peachtree Hematology - Oncology Consultants, PC, Atlanta, Georgia 30309, United States
Augusta Oncology Associates, PC, Augusta, Georgia 30901, United States
Northwest Georgia Oncology Centers, PC, Marietta, Georgia 30060, United States
Jayne Gurtler, MD, Laura Brinz, MD , & Angelo Russo, MD, Metairie, Louisiana 70006, United States
Hematology, Oncology Centers of the Northern Rockies, PC, Billings, Montana 59101, United States
NorthEast Oncology Associates, Concord, North Carolina 28025, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania 19106, United States
Charleston Cancer Center, Charleston, South Carolina 29406, United States
Arlington Cancer Center, Arlington, Texas 76012, United States
Center for Oncology Research and Treatment, PA, Dallas, Texas 75230, United States
Additional Information
Starting date: May 2006
Ending date: May 2008
Last updated: May 8, 2008
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